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Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management (QM) therefore incorporates Good Manufacturing Practice (GMP).Good Laboratory Practices (GLP) define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.Good Hygiene Practice (GHP) is to include, upkeep of the facilities, pest control, waste control, use of protective clothing, cleaning and sanitization of equipment including maintenance, and the selection and use of chemicals etc.COURSE AGENDA1 INTRODUCTION 2 GENERAL DEFINITIONS 2_1 GENERAL DEFINITIONS-I 2_1_1 DRUG PRODUCT (PHARMACEUTICAL PRODUCT) 2_1_2 ACTIVE PHARMACEUTICAL INGREDIENT (API) 2_1_3 STARTING MATERIAL 2_1_4 INTERMEDIATE PRODUCT 2_1_5 PACKAGING MATERIAL 2_1_6 BULK PRODUCT 2_1_7 FINISHED PHARMACEUTICAL PRODUCT (FPP) 2_1_8 MANUFACTURING FLOW CHART 2_2 GENERAL DEFINITIONS-II 2_2_1 PRODUCTION 2_2_2 PACKAGING 2_2_3 MANUFACTURE (MANUFACTURING) 2_2_4 MANUFACTURER 2_2_5 MARKETING AUTHORIZATION (PRODUCT LICENCE) (REGISTRATION CERTIFICATE) 2_2_6 QUALITY ASSURANCE 2_2_7 QUALITY CONTROL 2_2_8 IN-PROCESS CONTROL 2_3 GENERAL DEFINITIONS-III 2_3_1 STANDART OPERATING PROCEDURE (SOP) 2_3_2 BATCH (LOT) 2_3_3 BATCH NUMBER (LOT NUMBER) 2_3_4 BATCH RECORD 2_3_5 MASTER RECORD 2_3_6 MASTER FORMULA 2_3_7 SPECIFICATION 2_3_8 AUTHORIZED PERSON 2_4 GENERAL DEFINITIONS-IV 2_4_1 CLEAN AREA 2_4_2 CONTAMINATION 2_4_3 CROSS CONTAMINATION 2_4_4 HVAC (HEATING, VENTILATION AND AIR CONDITIONING) 2_4_5 AIRLOCK 2_4_6 AIRLOCK TYPES (PERSONNEL & MATERIAL) 2_4_7 AIRLOCK TYPES (PRESSURE MOVEMENT) 2_5 GENERAL DEFINITIONS-V 2_5_1 CALIBRATION 2_5_2 QUALIFICATION 2_5_3 TYPES OF QUALIFICATION 2_5_4 VALIDATION 2_5_5 TYPES OF VALIDATION 3 PHARMACEUTICAL QUALITY SYSTEM 3_1 QUALITY MANAGEMENT 3_2 ROLES OF PHARMACEUTICAL QUALITY SYSTEM 3_3 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 3_3_1 GOOD MANUFACTURING PRACTICE (GMP) 3_3_2 BASIC REQUIREMENTS OF GMP 3_4 QUALITY CONTROL 3_4_1 QUALITY CONTROL 3_4_2 BASIC REQUIREMENTS OF QUALITY CONTROL 3_5 PRODUCT QUALITY REVIEW 3_5_1 PRODUCT QUALITY REVIEW 3_5_2 BASIC REQUIREMENTS OF PRODUCT QUALITY REVIEW 4 PERSONNEL 4_1 PERSONNEL 4_1_1 PERSONNEL 4_1_2 QUALIFICATION & PRACTICAL EXPERIENCE 4_1_3 ORGANIZATIONAL CHART 4_1_4 QUALIFICATION & RESPONSIBILITIES 4_1_5 JOB DESCRIPTION & RESPONSIBILITIES 4_2 KEY PERSONNEL 4_2_1 KEY MANAGEMENT PERSONNEL 4_2_2 RESPONSIBILITIES OF THE HEAD OF PRODUCTION DEPARTMENT 4_2_3 RESPONSIBILITIES OF THE HEAD OF QUALITY CONTROL DEPARTMENT 4_3 TRAINING 4_3_1 PERSONNEL TRAINING 4_3_2 BASIC TRAINING AND NEWLY RECRUITED PERSONNEL TRAINING 4_3_3 TRAINING FOR PERSONNEL WORKING IN HAZARDOUS AREAS 4_3_4 TRAINING FOR VISITORS OR UNTRAINED PERSONNEL 4_4 PERSONNEL HYGIENE 4_4_1 PERSONNEL HYGIENE 4_4_2 PERSONNEL HYGIENE PROCEDURES 4_4_3 PERIODIC MEDICAL EXAMINATION 4_4_4 PROTECTIVE GARMENTS 4_4_5 PROHIBITIONS IN GMP AREA 5 PREMISES AND EQUIPMENT 5_1 PREMISES-GENERAL 5_1_1 PREMISES AND EQUIPMENT 5_2 PREMISES-PRODUCTION AREA 5_2_1 FACILTY DESIGN FOR MINIMISING OF CROSS CONTAMINATION IN PRODUCTION AREA 5_2_2 QUALITY RISK MANAGEMENT FOR PREMISES AND EQUIPMENT PLACED IN PRODUCTION AREA 5_2_3 INTERIOR SURFACE REQUIREMENTS IN PRODUCTION AREA 5_2_4 HVAC DESIGN AND LIGHT FITTINGS IN PRODUCTION AREA 5_2_5 DRAINAGES IN PRODUCTION AREA 5_2_6 WEIGHING AREA IN PRODUCTION DEPARTMENT 5_2_7 CLEANING IN-PROCESS CONTROL IN PRODUCTION AREA 5_3 PREMISES-STORAGE AREA 5_3_1 STORAGE AREAS 5_3_2 CONDITIONS OF STORAGE AREAS 5_3_3 QUARANTINE STATUS OF STORAGE AREAS 5_3_4 SEGREGATED AREAS FOR REJECTED, RECALLED OR RETURNED AREAS 5_4 PREMISES-QUALITY CONTROL AREAS 5_5 EQUIPMENTS 5_5_1 EQUIPMENT 5_5_2 CLEANING OF EQUIPMENT 6 DOCUMENTATION 6_1 DOCUMENTATION 6_2 SPECIFICATIONS 6_2_1 SPECIFICATIONS 6_2_2 SPECIFICATIONS FOR STARTING AND PACKAGING MATERIALS 6_2_3 SPECIFICATIONS FOR FINISHED PRODUCTS 6_3 MANUFACTURING FORMULA 6_4 PROCESSING INSTRUCTIONS 7 PRODUCTION 7_1 PRODUCTION 7_2 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 7_2_1 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 7_2_2 TECHNICAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION 7_2_3 ORGANISATIONAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION 7_3 STARTING MATERIALS 7_4 PROCESSING OPERATIONS 7_4_1 PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCT 7_4_2 PROCESSING OPERATIONS: FINISHED PRODUCT 8 QUALITY CONTROL 8_1 QUALITY CONTROL 8_1_1 QUALITY CONTROL 8_1_2 RESPONSIBILITIES OF QUALITY CONTROL 8_1_3 FINISHED PRODUCT ASSESMENT 8_2 GOOD LABORATORY PRACTICE 8_2_1 GOOD LABORATORY PRACTICE 8_2_2 GOOD LABORATORY PRACTICE: DOCUMENTATION 8_2_3 GOOD LABORATORY PRACTICE: SAMPLING 8_2_4 GOOD LABORATORY PRACTICE: TESTING 8_2_5 GOOD LABORATORY PRACTICE: STABILITY 9 COMPLAINTS, QUALITY DEFECTS AND PRODUCT RECALLS 9_1 PERSONNEL AND ORGANISATION 9_2 PROCEDURES FOR HANDLING AND INVESTIGATING COMPLAINTS 10 CONCLUSION

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